Triple Target Treatment (3T) Which Combines Stimulation With Amplitude Modulated Middle Frequency (AM-MF), Electromyography (EMG)-Triggered Stimulation and EMG-Biofeedback Compared With EMG-Biofeedback in Anal Incontinence (3T-AI)

University of Giessen

Status and phase: Completed; Phase 3

Conditions: Fecal Incontinence

Treatments: Device: EMG-biofeedback alone; Device: Combination of EMG-biofeedback plus EMG-triggered AM-MF-stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT00525291

83/07 ethics comm. Giessen

Details and patient eligibility

About

The efficacy of biofeedback and/or low frequency electrical stimulation for the treatment of anal incontinence has not been proven. First, large well-designed clinical trials are missing. Second, only few patients reach therapeutically relevant intensities with low frequency stimulation. In this study, a novel therapeutic concept, termed triple target treatment (3T) was evaluated. 3T combines stimulation with amplitude modulated middle frequency (AM-MF), electromyography (EMG)-triggered stimulation and EMG-biofeedback. 3T was compared with EMG-biofeedback alone after a nine month treatment period.

Methods In this parallel-group randomised multicenter study with blinded observer we enrolled 158 patients with anal incontinence. Primary endpoints were changes from baseline to nine months in the Cleveland Clinic Score (CCS) and the St. Mark's score (Vaizey score).

Enrollment: 158 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All Patients with fecal incontinence I-III.

Exclusion criteria

• All Patients with CID´s
• Definite or possible pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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158 participants in 2 patient groups

EMG-biofeedback plus EMG-triggered AM-MF-stimulation

Experimental group

Treatment:

Device: Combination of EMG-biofeedback plus EMG-triggered AM-MF-stimulation

EMG-biofeedback alone

Active Comparator group

Treatment:

Device: EMG-biofeedback alone